Senior Analyst in audit and regulatory support at LPL Financial. Ensuring operational efficiency and compliance in the New Accounts Operations department.
About the role
- Senior Regulatory Affairs Manager ensuring compliance in clinical trials and market products for Amgen. Leading European regulatory strategies and submissions from clinical trials to marketing authorisation.
Responsibilities
- Work to ensure that Amgen acquires and maintains all the required licenses
- Advise the GRT on regional considerations in developing strategy
- Develop and execute regional regulatory product strategies
- Plan and manage regulatory submissions for products within Amgen's portfolio
- Implement product related regulatory strategies, Regulatory Affairs processes and activity planning
- Lead development of regional regulatory documents and meetings in accordance with GRT strategy
- Provide regulatory direction on regional regulatory mechanisms to optimize product development
- Advise on regulatory implications related to global clinical development plans and objectives
- Lead Health Authority and Agency Interactions and document and communicate outcomes appropriately
Requirements
- Degree educated in a scientific discipline
- Extensive experience in regional regulatory environment
- Proven track record of developing and executing regional regulatory strategy
- In-depth understanding of the drug life cycle and development process from a regulatory perspective
- In-depth understanding of the registration procedures in region for MA, post approval changes, extensions and renewals.
- Ability to lead teams and work collaboratively in a dynamic environment
- Proactive approach to problem solving
- Ability to understand and communicate scientific/clinical information
- Ability to anticipate regulatory agency expectations
- Strong awareness of the needs of internal and external stakeholders, and the role of Regulatory Affairs in driving successful drug development
Benefits
- Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
- Growth opportunities to learn and move up and across our global organization
- Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Job title
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Not specified
Degree requirement
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